Graft-Versus-Host Disease
Conditions
Keywords
Corticosteroids
Brief summary
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
Interventions
DRUGPentostatin
Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids * No chronic GVHD * Age ≥ 18 years * Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l) * Performance status 0-3
Exclusion criteria
* Patients on mechanical ventilation or who have resting O2 saturation \<90% by pulse-oximetry. * Patients on renal dialysis or who have an estimated creatinine clearance of \< 30 ml/min/1.73 m2. * Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease). | up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC). | up to 2 years |
Countries
United States
Outcome results
None listed